BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith announces an investigation on behalf of Zosano Pharma Corporation (“Zosano” or the “Company”) (NASDAQ: ZSAN) investors concerning the Company’s possible violations of federal securities laws.
On September 30, 2020, the Company revealed that it received “a discipline review letter (DRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA).” According to the Zosano’s press release, the FDA “raised questions regarding unexpected high plasma concentrations of zolmitriptan observed in five study subjects from two pharmacokinetic studies and how the data from these subjects affect the overall clinical pharmacology section of the application.” The FDA also “raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company’s clinical trials.”
On this news, the Company’s stock price fell $0.92 per share, or 57%, to close at $0.70 per share on October 1, 2020.
On October 21, 2020, the Company disclosed receipt of a Complete Response Letter (“CRL”) from the FDA. As a result of the inconsistencies identified in the DRL, the FDA recommended that the Zosano conduct a repeat bioequivalence study between three of the lots used during development.
On this news, Zosano’s stock price fell $0.17 per share, or 27%, to close at $0.4441 per share on October 21, 2020.
If you purchased Zosano securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to email@example.com, or visit our website at www.howardsmithlaw.com.
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